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Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00203164
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:
This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: rasagiline mesylate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy
Study Start Date : May 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: rasagiline mesylate
rasagiline mesylate 1 mg oral once daily
 Drug: rasagiline mesylate
rasagiline mesylate 1 mg oral once daily


Outcome Measures
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Primary Outcome Measures :
  1. long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy [ Time Frame: until commericially available ]
    To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
  • Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
  • Patients must be willing and able to give informed consent.

Exclusion Criteria:

  • Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
  • Premature discontinuation from study TVP 1012/133 for any reason.
  • A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203164


Locations
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United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
United States, Illinois
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.
More Information
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Responsible Party: Siyu Liu, MD, PhD, VP IRD, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
ClinicalTrials.gov Identifier: NCT00203164    
Other Study ID Numbers: TVP - 1012/135 Open Label
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs